INSPIRatory Efforts Estimation Under High-flow Nasal Oxygen: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The detection of estimated inspiratory efforts under HFNO in patients breathing through the nose at a flow rate of 30 L/min in at least 16 of the 20 (≥ 80%) patients included.
研究概览
简要总结
High-flow nasal oxygen (HFNO) is recommended as first-line treatment to prevent intubation in acute hypoxemic respiratory failure and to prevent reintubation after extubation. Accumulating data suggest that strong inspiratory efforts and their persistence are associated with HFNO failure. However, tools to monitor continuously and noninvasively inspiratory efforts are lacking. The investigators have developed an algorithm estimating noninvasively inspiratory efforts under HFNO. This pilot study aims at testing the feasibility of estimating inspiratory efforts in patients treated with HNFO.
详细描述
High-flow nasal oxygen (HFNO) is recommended as first-line treatment to prevent intubation in acute hypoxemic respiratory failure and to prevent reintubation after extubation (alone in patients at low-risk of extubation failure, alternating with noninvasive ventilation in patients at high-risk of extubation failure). It consists in delivering high flow of heated and humidified gas enriched with oxygen through nasal cannulas. However, HFNO failure occurs in 30 to 50% of cases in acute hypoxemic respiratory failure and 10 to 20% of cases after extubation.
Accumulating data suggest that strong inspiratory efforts and their persistence are associated with HFNO failure. However, the monitoring of inspiratory efforts is challenging, especially in patients breathing spontaneously through the nose under HFNO. On a bench study, the investigators have developed an algorithm estimating noninvasively inspiratory efforts under HFNO based on the analysis of tracings of pressure and flow delivered by the HFNO device using an extracorporeal sensor. The coefficient of determination of the algorithm was high (R2=0.92). This pilot study aims at testing the feasibility of estimating inspiratory efforts in patients treated with HNFO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 yo admitted to the intensive care unit
- •Treated with HFNO for less than 24h to prevent intubation of reintubation
- •Affiliated to social insurance
- •Consent to participate in the study
排除标准
- •Do-not-intubate order at inclusion
- •Already included in the study
- •Under legal protection
研究组 & 干预措施
Critically ill patients treated with HFNO
Patients treated with HFNO for less than 24 hours in ICU
干预措施: Non-invasive estimation of inspiratory effort (Other)
结局指标
主要结局
The detection of estimated inspiratory efforts under HFNO in patients breathing through the nose at a flow rate of 30 L/min in at least 16 of the 20 (≥ 80%) patients included.
时间窗: Day 1
Inspiratory efforts will be calculated a posteriori using the algorithm developed on the bench, based on the pressure and flow signals delivered by the HFNO device collected during the first recording.
次要结局
- Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min between HFNO success and failure in the overall population and in each subgroup (prevention of intubation and of reintubation)(Day 7)
- Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min between survivors and non survivors at day 28 in the overall population and in each subgroup (prevention of intubation and of reintubation)(Day 28)
- Inspiratory efforts estimated under HFNO according to dyspnea at each visit(Day 1)
- Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min between HFNO success and failure in the overall population and in each subgroup (prevention of intubation and of reintubation)(Day 7)
- Inspiratory efforts estimated under HFNO in patients breathing through the nose at a flow rate of 30 L/min between survivors and non survivors at day 28 in the overall population and in each subgroup (prevention of intubation and of reintubation)(Day 28)
- The change in inspiratory efforts between the 2 visits between HFNO success and failure in the overall population and in each subgroup (prevention of intubation and of reintubation)(Day 7)
- The change in inspiratory efforts between the 2 visits between survivors and non survivors at day 28 in the overall population and in each subgroup (prevention of intubation and of reintubation)(Day 28)
- Inspiratory efforts estimated under HFNO according to dyspnea at each visit(Day 1)